Enforcement policyCare Quality Commission enforcement policy
2
The Care Quality Commission is the independent regulator of health
and adult social care in England. Our purpose We make sure health
and social care services provide people with safe, effective,
compassionate, high-quality care and we encourage care services to
improve. Our role We monitor, inspect and regulate services to make
sure they meet fundamental standards of quality and safety and we
publish what we find, including performance ratings to help people
choose care.
Care Quality Commission enforcement policy 3
Contents
1. Purpose and principles of enforcement
...............................................................................
7
Purpose of enforcement
..............................................................................................................
7 Principles that guide the use of our enforcement powers
............................................................
7
2. Our approach to using our enforcement powers
..............................................................
11
What we can enforce
.................................................................................................................
11 Our enforcement powers and how they correspond to the purpose of
our enforcement ........... 13 How we select the appropriate
enforcement power
...................................................................
15 Sector enforcement priorities
....................................................................................................
16
3. Requiring improvement to protect people from harm or the risk of
harm ..................... 18
Requirement Notices
.................................................................................................................
18 Warning Notices
........................................................................................................................
18
4. Using civil powers to protect people from harm or the risk of
harm and to improve care standards
.................................................................................................................................
20
Impose, vary or remove conditions of registration
.....................................................................
20 Suspend registration
..................................................................................................................
21 Cancel registration
.....................................................................................................................
21 Deciding when to use conditions, suspension or cancellation
.................................................... 22 Urgent
procedures
.....................................................................................................................
22 Non-compliance by a provider following the exercise of these
powers ...................................... 23 Special
administration for NHS trusts and foundation trusts
..................................................... 23 Special
measures
.......................................................................................................................
24
5. Holding providers and individuals to account
...................................................................
26
CQC’s new powers in prosecution
..............................................................................................
26 Enforcement powers we will use to hold a provider to account
(criminal powers) ..................... 28 Simple cautions
.........................................................................................................................
28 Penalty notices
..........................................................................................................................
28 Prosecution
...............................................................................................................................
29 Holding individuals to account through criminal prosecutions or
using other powers................ 30 Unregistered providers
..............................................................................................................
30
6. Representations and appeals
.............................................................................................
32
Representations
.........................................................................................................................
32
Appeals......................................................................................................................................
32
Appendix: Offences and fines
................................................................................................
34
Fixed penalties
..........................................................................................................................
34 Prosecution
...............................................................................................................................
35
Care Quality Commission enforcement policy 4
Introduction
Enforcement is one of the core components of the operating model
(figure 1) that the Care Quality Commission (CQC) uses to achieve
its purpose and perform its role. This policy sets out the
principles and approach we will follow when using our enforcement
powers under the Health and Social Care Act 2008, as amended by the
Care Act 2014, to improve health and adult social care services and
protect the health, safety and welfare of people who use them. This
policy takes effect from 1 April 2015 and replaces the previous
enforcement policy. Where we have commenced enforcement action
prior to 1 April but it has not been completed, we will be guided
by this policy but we may continue to operate under the previous
policy if that is more appropriate to the facts of an individual
case. Figure 1: CQC’s operating model
The policy particularly concerns enforcement of the Health and
Social Care Act 2008, the Health and Social Care Act 2008
(Regulated Activities) Regulations 20141, and the Care Quality
Commission (Registration) Regulations 2009.2 In this policy, we
refer to both sets of regulations as ‘the regulations’. 1 As
amended by a) Health and Social Care Act 2008 (Registration and
Regulated Activities (Amendment) Regulations 2015 and b) The Health
and Social Care Act 2008 (Regulated Activities) (Amendment)
Regulations 2012.
2 As amended by a) The Care Quality Commission (Registration) and
(Additional Functions) and Health and Social Care Act 2008
(Regulated Activities) (Amendment) Regulations 2012 and b) The Care
Quality Commission (Registration and Membership) (Amendment)
Regulations 2012.
Care Quality Commission enforcement policy 5
Note that there will be occasions when, depending on the facts of
an individual case, it will not be appropriate to follow the
precise steps described in this policy. Therefore it should be read
as a general guide to good practice when carrying out or
considering to carry out enforcement action. It cannot substitute
for judgement in individual cases. There are many places in this
policy where we describe the steps we will take if there has been a
breach of the statutory duties of the registrant, a breach of the
regulations, or where there are risks to people using services.
Decisions about these matters, and whether to proceed to the next
state of enforcement action, should be based on the information
available to CQC at that time. We accept that there will be
occasions when more facts emerge later in the process, or disputes
of fact are resolved, and therefore enforcement action is no longer
required. If inspectors believe such a stage has been reached, CQC
will cease enforcement. When we refer in this policy to a breach of
statutory duties, a breach of the regulations, and risks to people
using services this means that it appears to the CQC that there has
been a breach of the statutory duties, a breach of the regulations
or there are risks to people using services. When we refer in this
policy to ‘failures’ by a registered provider or others, this means
we are referring to a breach of the statutory duties, a breach of
the regulations or where the actions or omissions of the provider
or others have led to unacceptable risks to people using
services.
Related guidance documents and legislation This policy should be
read alongside our other key guidance documents: • Our ‘enforcement
decision tree’ for selecting appropriate enforcement powers.
• Our provider handbooks that describe our approach to inspecting,
regulating and, where applicable, rating each of our care
sectors.
• Our guidance for providers on meeting the regulations.
This policy does not cover the Ionising Radiation (Medical
Exposure) Regulations 2000. These are covered under separate
primary legislation and have their own enforcement guidance,
available on our website. The policy also does not include use of
section 48 of the Health and Social Care Act 2008 to carry out
investigations. CQC has powers under the Regulation of
Investigatory Powers Act 2000 to use directed surveillance and
covert human intelligence sources. These powers are subject to
additional guidance, available on our website.
Care Quality Commission enforcement policy 6
Key points • We are the primary enforcement body at a national
level in England for ensuring that people
using health and adult social care services receive safe services
of the right quality.
• We have a wide range of enforcement powers and this policy sets
out our approach to using our powers.
• We will seek to use a structured decision process to help us
decide:
– Which cases should result in enforcement action.
– Which enforcement powers we should use.
– Which approach we should take when using our powers.
• This policy takes effect from 1 April 2015 and replaces the
previous enforcement policy.
Care Quality Commission enforcement policy 7
1. Purpose and principles of enforcement
Purpose of enforcement We have two primary purposes when using our
enforcement powers: 1. To protect people who use regulated services
from harm and the risk of harm, and
to ensure they receive health and social care services of an
appropriate standard.
• We may work with a provider without using enforcement powers to
improve standards where the quality or safety of a service is below
the required standards but we assess the risk of harm is not
immediate and we consider the provider should be able to improve
standards on their own
• We may take enforcement action to compel improvement where the
quality or safety of a service has fallen to unacceptable levels,
especially where there is a risk of harm to service users. In such
cases we may intervene directly (for example, to restrict a
service) or trigger others to intervene.
2. To hold providers and individuals to account for failures in how
the service is
provided.
• We have powers to pursue criminal sanctions when there has been a
breach of the fundamental standards of quality and safety or some
other criminal offence.
• Using the full range of our enforcement powers, including
criminal sanctions, should ensure that providers are focused on the
need to provide services that meet Parliament’s regulatory
requirements.
When a service falls below the required standards, we will consider
both purposes.
Principles that guide the use of our enforcement powers We will use
our enforcement powers to promote our statutory objective of
protecting and promoting the health, safety and welfare of people
who use health and social care services. The following five
principles will guide our decision-making: 1. Being on the side of
people who use regulated services • We recognise that providers
often have greater power, control or information than service
users. Misusing this power can prevent people from receiving high
quality care services. Where appropriate, we are prepared to use
the full range of our powers to ensure that people who use
regulated services receive safe, effective, compassionate, high
quality care to the standards set by Parliament.
• The starting point for considering the use of all enforcement
powers is to assess the harm or the risk of harm to people using a
service.
Care Quality Commission enforcement policy 8
• We will not tolerate breaches that add up to inadequate care,
whether they give rise to a risk of harm or not. Where there are
failures in care that do not improve, we will be prepared to use
our enforcement powers.
• We will have regard to the interests of people using care
services and others affected by any failure in care as part of
considering how to use our enforcement powers.
2. Integrating enforcement into our regulatory model • Enforcement
is a core part of CQC’s operating model. Our approach to
enforcement is central
to our overall purpose and objectives as a regulator. We do not
have a separate approach or separate staff for enforcement. Our
various functions are designed so they are supported by our
enforcement role, and all inspectors are trained so that their
engagement with a provider covers all aspects of the regulatory
relationship, including enforcement.
• For those providers that we rate, enforcement joins up with (but
is not synonymous with) our approach to rating overall quality. We
will generally take a broad view when using our enforcement powers
as opposed to reacting to individual events and concerns.
Enforcement action must relate to specific breaches of legal
obligations, but our decision whether to use enforcement powers may
take account of a wide range of factors including whether a
provider has ratings of requires improvement or inadequate. In
particular, we will consider whether the provider has a history of
repeated ratings of inadequate.
• Table 1 sets out the relationship between the ratings and the
regulations. Our inspections first assess if the care provided is
good. Where it is not, we will explore if care requires improvement
or is inadequate. At that stage, we will consider whether any of
the regulations are being breached. For care to be rated as
requires improvement, it does not necessarily mean there is a
breach of a regulation. Where care falls below the standard
required by the regulations, it will at best be rated as requires
improvement. Care rated as inadequate will normally be in breach of
regulations.
• While we publish ratings for most providers registered with us,
the regulations apply to everyone, including those registered
providers for whom we do not publish ratings. We will apply this
policy to consider whether we should take enforcement action
against providers and others where we find breaches of the
regulations.
Care Quality Commission enforcement policy 9
Table 1: Relationship between the ratings and the regulations
Overall rating Level of meeting the regulations High-level
characteristics of each rating level
Inadequate Providers rated as inadequate are generally likely to be
not meeting the standards set in the regulations (with the possible
exception of the well-led rating, which is not completely covered
by the regulations).
Significant harm has occurred or is likely to occur. There are
shortfalls in practice and ineffective action or no action has been
taken to put things right or improve standards.
Requires improvement
Providers rated as requires improvement may or may not be meeting
the standards set out in the regulations.
Providers may have elements of good practice, but provide
inconsistent standards of care. This gives rise to potential or
actual risk to people using services and/or the provider gives
inadequate or inconsistent responses when things go wrong.
Good Providers rated as good are meeting the standards set out in
the regulations and display the characteristics of good care (that
is, to be rated good means more than just meeting the standards set
out in the regulations).
Providers demonstrate a consistent level of service that meets or
exceeds the regulatory standards. The provider has robust
arrangements in place for when things go wrong.
Outstanding Providers rated as outstanding are meeting the
regulations and display the characteristics of outstanding
care.
Providers are innovative and creative, and are constantly striving
to improve standards. They are open and transparent.
3. Proportionality • We will only take action that we judge to be
proportionate. This means that our response,
including the use of enforcement powers, must be assessed by us to
be proportionate to the circumstances of an individual case. Where
appropriate, if the provider is able to improve the service on
their own and the risks to people who use services are not
immediate, we will generally work with them to improve standards
rather than taking enforcement action. We generally intervene if
people are at an unacceptable risk of harm or providers are
repeatedly or seriously failing to comply with their legal
obligations.
Care Quality Commission enforcement policy 10
4. Consistency • We will seek to be consistent in applying our
enforcement powers by, as far as possible,
dealing with similar cases in a similar manner. However the facts
in one case, including the provider’s past history, are rarely
replicated precisely in another case. We recognise that, even
though we seek to achieve broad consistency, we will take different
decisions in cases where the facts are not the same.
o Consistency does not mean that we will use the same enforcement
option every time a particular legal requirement is breached. We
will seek to use the principles and processes set out in this
policy to decide how to respond to breaches of regulations or
breaches of the relevant requirements.
o We will train and support our staff to promote consistency in our
approach and our responses to regulatory breaches.
5. Transparency • We will strive to be open and transparent about
our approach to enforcement, consistent
with how we effectively carry out our functions.
o This enforcement policy is available in a variety of formats,
which can be obtained on request. This means providers, the public,
and other oversight organisations can easily understand what we
expect of providers and how we approach cases where they do not
meet the requirements of the law. We will also publish related
information including the criteria we use to make decisions and
processes for appeals and making representations against our
decisions.
o We will publish information about our enforcement activity and
include it in management information reported to our public Board
meetings.
o We will consult on any proposed changes to this enforcement
policy.
Care Quality Commission enforcement policy 11
2. Our approach to using our enforcement powers
What we can enforce First, providers of any regulated activity in
England must be registered with CQC. We can take enforcement
against anyone who provides regulated activities without
registration (described in section 5 of this policy). Second, we
can take enforcement against registered persons (meaning registered
providers and/or registered managers) who breach: • Conditions of
registration.
• Relevant sections of the Health and Social Care Act 2008, the
Care Quality Commission (Registration) Regulations 2009, the Health
and Social Care Act 2008 (Regulated Activities) Regulations 2014,
and other legislation that is relevant to achieving registration
requirements.
The Health and Social Care Act 2008 (Regulated Activities)
Regulations 2014 introduced the fundamental standards that come
into force for all registered providers on 1 April 2015. These
regulations are more focused than the previous regulations, and
some allow direct prosecution when the standards are breached. The
steps that a provider should have regard to in meeting these
standards are set out in our statutory guidance for providers.
Where breaches of regulations do not constitute a criminal offence,
we can enforce the standards by using our civil powers to impose
conditions, suspend a registration or cancel a registration.
Failure to comply with the steps required when we use our civil
powers is a criminal offence and so may result in a prosecution.
The breaches of the regulations that constitute criminal offences
are shown in bold in table 2.
Table 2: Regulations for which breaches constitute criminal
offences (shown in bold)
Health and Social Care Act 2008 (Regulated Activities) Regulations
2014
Additional notes
Regulation 9: Person-centred care
Regulation 12: Safe care and treatment*
Regulation 13: Safeguarding service users from abuse and improper
treatment*
Regulation 14: Meeting nutritional and hydration needs*
Regulation 15: Premises and equipment
Regulation 16: Receiving and acting on complaints
Regulation 17: Good governance
Regulation 20: Duty of candour*
Regulation 20A: Requirement as to display of performance
assessments*
*These regulations relate specifically to harm or the risk of harm,
or are requirements imposed by CQC. Breach of these regulations is
a criminal offence and CQC is able to move directly to prosecution
without first serving a Warning Notice.
In addition, Regulation 16: Receiving and acting on complaints and
Regulation 17: Good governance have clauses that require
information to be provided to CQC on request.
It is an offence to fail to comply with such a request. Not
providing the information could prevent CQC from identifying and
responding to harm or risk of harm in a timely and appropriate
manner. If these clauses are breached, CQC may move to
prosecution.
Care Quality Commission (Registration) Regulations 2009
Regulation 12: Statement of purpose
Regulation 13: Fees etc
Regulation 16: Notification of death of service user
Regulation 17: Notification of death or unauthorised absence of a
person who is detained or liable to be detained under the Mental
Health Act 1983
Regulation 18: Notification of other incidents
Regulation 19: Fees etc
Care Quality Commission enforcement policy 13
Our enforcement powers and how they correspond to the purpose of
our enforcement We have two purposes when we use our enforcement
powers (illustrated in figure 2): 1. To protect people who use
regulated services from harm and the risk of harm, and to
ensure
they receive health and social care services of an appropriate
standard. We can do this by either requiring or forcing
improvement.
2. To hold providers and individuals to account for failures in how
a service is provided.
Care Quality Commission enforcement policy 14
Figure 2: CQC’s enforcement powers and how they relate to the
purpose of our enforcement
*Section 29A only relates to NHS trusts (including foundation
trusts).
• Requirement Notices (formerly known as ‘compliance
actions’)
• Warning Notices • Section 29A Warning Notices*
Purpose: Protecting people who use services by requiring
improvement
––––––––––––––––––––– Increasing severity
––––––––––––––––––––>
registration • Suspending registration • Cancelling registration •
Urgent procedures
Special measures • Time-limited approach ensures inadequate
care is not allowed to continue • Coordination with other oversight
bodies
Purpose: Protecting people who use services by forcing
improvement
Criminal powers • Simple cautions • Penalty notices •
Prosecution
Holding individuals to account • Fit and proper person requirement
• Prosecution of individuals
Purpose: Holding providers and individuals to account for
failure
Care Quality Commission enforcement policy 15
In addition to our statutory powers, we also work with other
oversight organisations to ensure that they take action on concerns
that we have identified. We will do so where that is more
proportionate or likely to be more effective than CQC acting on its
own. We always retain the option to use our legal enforcement
powers as appropriate, for example the development of special
measures for NHS trusts with Monitor and the NHS Trust Development
Authority, and the memorandums of understanding, information
sharing agreements and operational protocols that CQC has with
professional regulators. Where we believe that another body is best
placed to take action to improve standards we will work with that
other body to take that action. However, we will continue to
monitor the situation to make sure that improvement does happen. We
remain involved and do not assume that a concern has been addressed
until we have evidence that this is the case.
How we select the appropriate enforcement power We use a four-stage
decision-making process to reach enforcement decisions as described
in our ‘enforcement decision tree’. We have summarised our approach
for each stage of the decision tree below. While this policy sets
out our high-level approach, we have published further detail about
the decision tree and there is a summary version later in this
section (figure 3). 1. Initial assessment
Before commencing enforcement action, the first stage is to
consider the case at a structured management review meeting (MRM).
The overwhelming majority of cases will be followed up through
standard direct checks, such as focused inspections. Urgent cases
may proceed directly to evidence collection for potential urgent
action or prosecution. 2. Legal and evidential review
This stage checks that the evidence we hold demonstrates a breach
of the regulations or relevant requirements. It also ensures we
take account of our statutory guidance and any other relevant
legislation. It checks that the evidence is sufficient to enable us
to proceed to take enforcement action, and that the initial logging
and registering of evidence has been done correctly. 3. Selection
of the appropriate enforcement action
This stage leads inspectors through a series of tests to assist
them to make a decision about which enforcement option to make. The
enforcement decision tree sets out criteria that are used to assist
us in this decision-making process. The criteria are: • Seriousness
of the concerns.
• Evidence of multiple and/or persistent breaches. Stage 3A looks
at the seriousness of the concern and the facts that gave rise to
that specific concern. It does not take account of other incidents
that may have taken place nor the provider’s response to them. It
is an assessment of the likelihood of the concern happening again,
and if so, the impact it would have on people using the
service.
Care Quality Commission enforcement policy 16
Stage 3B takes account of other incidents that may have taken place
relating to this provider and the provider’s response. It requires
inspectors to consider whether there is evidence of systemic
failings in the quality of care and/or management, which will
result in recurrent issues. The outcome of the assessment at stage
3B can result in an increase or decrease to the severity of the
enforcement action we decide to take, as well as determining
whether we need to hold a provider and/or individual to account
through criminal sanctions. 4. Final review
The final decision about which enforcement action to pursue is made
at an MRM meeting where CQC’s sector enforcement priorities are
considered. These are the priorities set by CQC’s Board and agreed
in our business plan. They set expectations for our overall
approach to enforcement, providing a transparent message to the
sectors as well as to our inspectors. Consideration of these
priorities may result in a change to the type or severity of the
enforcement action we intend to take. The final review also checks
that the recommendation is in line with this enforcement policy,
and that the decision-making process has been followed in line with
CQC’s scheme of delegation, with appropriate legal advice, and with
a robust audit trail of decisions.
Sector enforcement priorities Each year, as part of developing the
coming year’s business plan, we review enforcement activity and
consider whether there are priorities that should be reflected in
the business plan. These priorities may differ by sector and are
set by the CQC board when it agrees the business plan. Enforcement
priorities do not override the terms of this policy, but are taken
into account.
Care Quality Commission enforcement policy 17
Figure 3: Enforcement decision tree
Initial assessment: • Consider and justify our response to concerns
identified
Stage 1
Legal and evidential review: • Is there a breach of regulations or
relevant
requirements? (legal check) • Is the evidence sufficient, credible
and appropriately
recorded? (evidential check)
Stage 2
Selection of the appropriate enforcement action: 3A: Seriousness of
the concern (the identified concern only) 3B: Multiple or
persistent breaches (all other incidents and
their management)
Stage 3
Final review: • Sector enforcement priorities • Management review
meeting (MRM) to decide
enforcement action (consider enforcement principles)
Stage 4
Care Quality Commission enforcement policy 18
3. Requiring improvement to protect people from harm or the risk of
harm
We use the following enforcement actions to require a provider to
protect people who use regulated services from harm and the risk of
harm, and to ensure they receive health and social care services of
an appropriate standard. These are:
Requirement Notices Where a registered person is in breach of a
regulation or has poor ability to maintain compliance with
regulations, but people using the service are not at immediate risk
of harm, we may use our power to require a report from the
provider. We will do this by serving a Requirement Notice on the
provider. The response from the provider to the Requirement Notice
must show how the provider will comply with their legal obligations
and must explain the action the provider is taking or proposes to
take to do so. Issuing a Requirement Notice notifies a provider
that we consider they are in breach of legal requirements and
should take steps to improve care standards. Failure to send us a
report in the timescale set out in the Requirement Notice is an
offence and could lead to us using other enforcement powers. We
will consider issuing a Requirement Notice where: • The provider is
acting in breach of the regulations; the impact on people using the
service is
not immediately significant; and we assess that the provider should
be able to improve its standards within a reasonable
timeframe.
• The provider has no history of poor performance that gives rise
to wider concerns.
Warning Notices Warning Notices notify a registered person that we
consider they are not meeting a condition of registration, a
requirement in the Health and Social Care Act 2008, a regulation,
or any other legal requirement that we think is relevant. We cannot
use Warning Notices against unregistered persons.
• Requirement Notices (formerly known as ‘compliance
actions’)
• Warning Notices • Section 29A Warning Notices
Purpose: Protecting people who use services by requiring
improvement
Care Quality Commission enforcement policy 19
We can serve Warning Notices about past failures to meet legal
requirements or about a continuing breach of a legal requirement.
Where a Warning Notice concerns a continuing breach of a legal
requirement, it will include a timescale by when improvements must
be achieved. If a registered person has not made the necessary
improvements within the timescale, we will consider further
enforcement action. This could lead to further action under civil
or criminal law. The enforcement decision tree published alongside
this policy specifically prompts inspectors to consider persistent
concerns and the ability to improve where concerns are identified.
We aim to follow up every Warning Notice through an appropriate
form of check (including unannounced focused inspections where that
is proportionate) within three months of the date set in the
notice. The regulations allow us to publish Warning Notices as long
as registered persons are given the opportunity in advance to make
representations about the proposed publication. Warning Notices
where significant improvement is required in an NHS trust or NHS
foundation trust3 There is additional provision in section 29A of
the Act for a Warning Notice that is addressed to NHS trusts or
foundation trusts. We may issue such a notice where we judge an NHS
trust requires significant improvement. Significant improvement is
not necessarily restricted to breaches of legislation but could be
broader. Our approach to using these Warning Notices is: • We will
use the same criteria for deciding whether to issue a notice under
section 29A as for
other Warning Notices.
• Where we do issue a notice under section 29A, we will set a
timescale for the significant improvements required to meet the
legal obligations of the NHS body or to address the matters set out
in the notice.
• We will allow the NHS body to make representations in the same
way as other Warning Notices and will have the same expectations
for publication and follow-up
• We may use notices under section 29A as part of the NHS single
failure regime. This is considered in section 4 of this policy as
part of special measures.
3 This power is expected to come into force on 1 April 2015. Until
it comes into force, ‘normal’ Warning Notices as in the section
above will apply to NHS trusts and foundation trusts.
Care Quality Commission enforcement policy 20
4. Using civil powers to protect people from harm or the risk of
harm and to improve care standards
We use the following civil enforcement powers to force a provider
to protect people who use regulated services from harm and the risk
of harm, and to ensure they receive health and social care services
of an appropriate standard. We can also use the special measures
framework to manage providers who are failing to comply with their
legal requirements.
Impose, vary or remove conditions of registration Registered
persons may have routine conditions attached to their registration.
These conditions may include the locations where the regulated
activity can be carried on or managed. Registration conditions are
usually agreed with registered persons when they apply for
registration. Imposing, varying or removing conditions of
registration is a flexible enforcement process that we can use in a
variety of different ways to ensure that providers comply with
their legal obligations and hence ensure that people who use
regulated services are kept safe and receive an acceptable standard
of care. For example, we may use a condition to stop a regulated
activity at one location but allow the provider to continue
providing services at their other locations. We can then remove the
condition once our specific concern has been addressed. Conditions
may be applied across a whole provider or targeted to specific
locations, or to services and activities at one location.
Civil enforcement powers • Imposing, varying or removing conditions
of
registration • Suspending registration • Cancelling registration •
Urgent procedures
Special measures • Time-limited approach ensures inadequate
care is not allowed to continue • Coordination with other oversight
bodies
Purpose: Protecting people who use services by forcing
improvement
Care Quality Commission enforcement policy 21
We may also impose conditions that require a registered person to
take further action where we consider that some specific
improvement is necessary. For example, we may use conditions to
ensure that action is taken to manage specific risks. We will not
seek to impose conditions that define precisely how a provider
should operate or manage its service. It should remain the
provider’s choice to decide precisely how to operate its business
as long as it complies with all relevant legal requirements.
However, we will retain the right to impose conditions to whatever
level of detail and prescriptiveness appear to us to be appropriate
in order to ensure that we can be confident that the provider will
operate its business in a way that complies with all relevant legal
requirements. Usually we will set out our concerns and frame
conditions such that they explain what we require to be achieved,
but leave the provider to determine exactly how that will be
delivered. For example, we may impose a condition requiring
staffing levels to take account of national guidance and to require
regular returns to us to demonstrate compliance. We will not
usually use a condition to define the precise staffing ratio that
the provider must achieve. We will seek to use conditions flexibly.
They can be used to formalise administrative arrangements, stop
risky activities or require specific improvements. We expect them
to be one of our most frequently used powers. Whenever possible we
will seek to agree the imposition of additional conditions or the
variation or removal of existing conditions with the registered
person in the first instance. If we cannot reach an agreement with
the registered person, or we believe that the level of risk will or
may increase, then we may rely on our urgent procedures to amend a
registered person’s conditions of registration.
Suspend registration We can suspend the registration of a
registered person for a specified period. We also have the power to
extend any period of suspension. We may use this power where there
is a very serious concern that we believe can be addressed within a
fixed period, for example to construct new buildings or hire new
staff. We anticipate rarely using this power. Suspension affects
all of the locations where the registered person carries on or
manages the relevant regulated activity. We will therefore pay
particular attention to the likely outcomes of suspending
registration before taking this action. However, suspension can
give a provider the chance to work towards meeting the standards
and then resume carrying on or managing an activity, and will be an
important proportionate option in specific circumstances. If
providers carry on providing a regulated activity when the
registered person has been suspended, this is an offence and we may
prosecute.
Cancel registration One of our most powerful sanctions is to cancel
a registration. As with suspension, this will affect all the
locations where the registered person carries on or manages the
relevant regulated activity. Cancellation normally follows
considerable efforts to get registered persons to meet the legal
requirements, including taking special measures as described later
in this section. However,
Care Quality Commission enforcement policy 22
where appropriate, we will use the cancellation process without
first having followed other processes. If providers carry on
providing a regulated activity when the registered person has been
cancelled, this is an offence and we may prosecute.
Deciding when to use conditions, suspension or cancellation We will
consider using conditions, suspension or cancellation where we
assess that people receiving regulated services:
• Have suffered harm or are at risk of harm because a registered
person is failing to comply
with legal requirements.
or
• Are receiving care services that substantially fail to meet the
standards set out in the regulations.
We will consider imposing conditions on the provider’s registration
if we assess that by imposing a condition it is likely to result in
the provider addressing the matters of concern within an acceptable
timescale. We will consider suspending a provider’s registration if
we assess that suspension is reasonably necessary to prevent the
breaches of the provider’s legal requirements but that the provider
will be able to provide a lawful service at an identifiable time in
the future. We will consider the cancellation of a registration if
we assess that the registered person does not have the capability
or the capacity to substantially comply with regulations, or is
likely to fail to do so.
Urgent procedures We have the right to exercise the power to impose
conditions or suspend a registration on an urgent basis. Where we
exercise these powers, our decisions have immediate effect.
Providers are entitled to appeal against the use of these urgent
powers but this does not prevent the condition or suspension taking
effect.
Cancelling a provider’s registration on an urgent basis If we wish
to cancel a provider’s registration using urgent procedures, we
must apply to a Justice of the Peace for a court order. In these
circumstances we will, where reasonably practicable: • Tell the
registered person in advance about our application to cancel their
registration using
urgent procedures.
• Only make an application without telling and involving the
registered person in exceptional circumstances, such as when their
whereabouts are not known and after we have made considerable
efforts to locate them.
Care Quality Commission enforcement policy 23
Where it is not practicable to give the registered person notice of
our application to a Justice of the Peace, we will make a full and
frank disclosure of all relevant evidence and confirm that we have
not given notice to the registered provider as part of our
application.
General provisions about the use of urgent powers When serving an
Order or Notice of Decision on a registered person using an urgent
procedure it will always include information about: • Our
memorandum of understanding with the First-tier Tribunal (Care
Standards) about a
'fast track' option for appeals.
• How the registered person can appeal against the urgent
cancellation order or notice. Urgent procedures are an important
part of our enforcement powers so that we can act quickly to
protect people using a registered service. We expect urgent
procedures to be a significant element of our enforcement activity
and we will also consider criminal sanctions in serious cases. We
will use urgent procedures in line with the thresholds set out in
the Health and Social Care Act 2008. This means that we will only
use these powers where we believe that: • Unless there is an urgent
use or amendment of conditions, or urgent suspension of
registration, a person will or may be exposed to harm.
• Unless we apply to a Justice of the Peace for the urgent
cancellation of registration, a person will be exposed to serious
risk to their life, health or wellbeing.
Non-compliance by a provider following the exercise of these powers
It is a criminal offence not to comply with conditions of
registration, or to continue to provide a regulated activity after
registration has been suspended or cancelled. CQC considers
breaches of such provisions can amount to a serious offence. This
approach is reflected in CQC’s criteria for prosecution. The
offence can apply to failure to comply with conditions, suspension
or cancellation for any reason. This means, for example, that in
relation to those regulations for which a breach does not in itself
amount to a criminal offence, a condition, suspension or
cancellation of registration may be imposed. Failure to comply with
that registration, suspension or cancellation could then result in
prosecution.
Special administration for NHS trusts and foundation trusts For NHS
foundation trusts, we have powers to require Monitor to appoint an
administrator and thereby place the foundation trust in ‘special
administration’. Special administration is a form of time-limited,
rules-based administration that will result in an administrator
making recommendations that are designed to ensure that the NHS
body improves its standards so that it provides secure, sustainable
and high quality services. These powers are set out in the
Care
Care Quality Commission enforcement policy 24
Act 2014. They are mirrored in the Secretary of State’s directions
to the NHS Trust Development Authority (NHS TDA), so that there are
also directly equivalent arrangements for NHS trusts. To use these
powers, we must first have issued a section 29A Warning Notice and
be satisfied that the provider has not complied with it. Before
requiring appointment of an administrator we will consult the
Secretary of State and Monitor or NHS TDA (as appropriate), and
then consult the provider, the board, anybody that the trust
provides services to, and any other people or organisations that we
judge appropriate. As with cancellation of registration, using this
power would normally follow considerable efforts to get the
provider to improve, including special measures as described
below.
Special measures Special measures are an administrative framework
which helps CQC to manage providers who are failing to comply with
their legal requirements and require a higher than usual level of
regulatory supervision. For these providers, special measures
assist us to deliver our statutory functions. Part of any special
measures regime is the effective use of enforcement powers to
ensure that improvements are made to the standard of care provided
by the registered provider. A provider who is operating under
special measures may also be working under the close supervision of
another oversight body. Where appropriate, we will work closely
with relevant oversight bodies to ensure improvements to the
standards of service provision are made by the registered provider.
The purpose of special measures is to: • Ensure that providers
found to be providing inadequate care do not continue to do
so.
• Provide a framework within which we can use our powers, including
enforcement powers, in response to inadequate care standards or
other regulatory failures.
• Provide a framework for us to work with other relevant oversight
bodies, including signposting the provider to another relevant
oversight body or other organisation, to assist in ensuring that
improvements in standards and regulatory compliance are
achieved.
• Provide a clear and consistent timeframe within which providers
are required to improve their quality of care so that they meet the
regulatory requirements. We are likely to seek to exercise our
powers to cancel their registration if the required improvements
are not made or, in the case of NHS trusts and foundation trusts,
use our powers to require that they are placed in special
administration.
Special measures only apply to services we regulate. They are
usually triggered by ratings of inadequate care, rather than by
individual breaches of regulations. Ratings of inadequate care will
generally include a breach of regulations, but they are a rounded
assessment of the overall effect for people of how a service is
provided, including how the provider meets individual regulations
within that.
Care Quality Commission enforcement policy 25
For services that we do not rate, or where an issue arises in a
rated service but it does not change the rating, we will usually
continue to use the full the range of our enforcement powers as
appropriate, without the special measures framework. We will still
be able to use our enforcement powers as appropriate during the
period when a provider is in special measures. Special measures
work differently in different types of service areas. For example:
• NHS trusts and foundation trusts, where we work closely with the
NHS TDA, Monitor and
others.
• Primary care, where we work closely with NHS England,
professional regulators and others.
• Other services, including adult social care and independent
healthcare, that do not all have a public sector commissioner, or
where services are operated by corporate providers or single
entities.
For each sector in which we use special measures, we will issue
relevant information alongside this policy, in line with its
principles and approach. Taking account of the characteristics of
the sector, the needs of people who use these services, and the
roles of other oversight bodies, improvement agencies and corporate
providers, this guidance always includes: • Clear entry criteria
that will trigger special measures, linked to inadequate
ratings.
• Time-limited periods for providers to make the necessary
improvements so that they are not providing inadequate care.
• Consideration of whether an extension of the time limit will be
possible, and if so in what circumstances, through a follow-up
inspection.
• Clear criteria for providers exiting special measures, linked to
improvement in ratings.
• A clear approach to providers that do not improve and continue to
have a rating of inadequate at the end of special measures.
We will work closely with other organisations or oversight bodies
in the system to ensure that providers do not continue to provide
inadequate care and that they improve during the special measures
period. It is the provider’s legal responsibility to improve and we
will work with the provider to make that happen. When one or more
of a provider’s services is placed in special measures, we will
assess the wider impact of this on the quality of care provided in
its other services. Special measures are also reflected in the
enforcement decision tree that we have published alongside this
policy. In particular, the criteria for the use of our power to
cancel registration will be triggered where serious concerns are
identified and have not been improved within the timeframe that we
set.
Care Quality Commission enforcement policy 26
5. Holding providers and individuals to account
We have a variety of methods we can use to hold providers and
individuals to account for failures in how the service is provided.
We also have new powers in relation to prosecution.
CQC’s new powers in prosecution The Health and Safety Executive
(HSE) (and for certain services, local authority health and safety
inspectors) have a key role in prosecuting serious safety
incidents. However, with the coming into force of the Health and
Social Care Act 2008 (Regulated Activities) Regulations 2014, CQC
is now able to prosecute cases where people using a registered
service are harmed or placed at risk of harm. We have developed and
published a memorandum of understanding, to set out how our roles
fit together and principles for managing cases that go across more
than one of these roles. • CQC is the lead inspection and
enforcement body for safety and quality of treatment and
care matters involving patients and service users in receipt of
health or adult social care service from a provider registered with
CQC.
• HSE/local authorities are the lead inspection and enforcement
bodies for health and safety matters involving patients and service
users who are in receipt of health or care service from providers
not registered with CQC.
• HSE/local authorities are the lead inspection and enforcement
bodies for health and safety matters involving workers, visitors
and contractors.
Our prosecution criteria (set out in the box below) ensure that
there is coherence in how we select cases for prosecution, and how
HSE/local authorities do so. These criteria are embedded within the
enforcement decision tree published alongside this policy.
Criminal powers • Simple cautions • Penalty notices •
Prosecution
Holding individuals to account • Fit and proper person requirement
• Prosecution of individuals
Purpose: Holding providers and individuals to account for
failure
Care Quality Commission enforcement policy 27
CQC’s prosecution criteria These criteria need to be applied as
part of the enforcement decision tree. We will consider prosecution
where there is evidence any of the following apply: • Services
which result in:
o Avoidable harm (whether of a physical or psychological nature) to
a service user, or o A service user being exposed to a significant
risk of such harm occurring, or o In a case of theft, misuse or
misappropriation of money or property, any loss by a service
user of the money or property concerned.
• Services that have been provided to individuals without informed
consent.
• There has been a failure to provide reports on complaints or good
governance.
• There has been a failure to legibly display ratings that relate
to performance at a provider’s premises and overall place of
business.
• There has been a failure to notify and offer support to the
relevant person following a notifiable safety incident.
• There has been disregard for, and/or attempted avoidance of, the
requirement for anyone who carries on regulated activities in
England to be registered with CQC.
• There has been a failure to comply with a requirement, Warning
Notice or condition, suspension or cancellation of registration; or
there has been a repetition of a breach that was subject to a
simple caution.
• False information has been supplied wilfully; information or
explanations have been withheld; or there has been an intent to
deceive, in relation to a matter that gives rise to significant
risk.
• Persons authorised by CQC to enter and inspect have been
intentionally obstructed in the lawful course of their
duties.
We will also consider the following factors when deciding whether
to prosecute: • The gravity of the incident, taken together with
the seriousness of any actual or potential
harm or the general record and approach of the provider, mean that
not holding the provider to account could undermine public
confidence in regulation or in that sector of providers.
• There has been disregard for the requirements on a registered
person.
• There have been repeated or multiple breaches, which give rise to
significant risk, or persistent and significant poor
compliance.
• The service is breaching fundamentals of care, namely that it has
been carried on significantly below the standards that are required
for compliance with regulations and is giving rise to significant
risk.
• The potential for wider learning points for providers may mean we
will prioritise a single case, so that enforcement sends a broader
message to a sector and encourages improvement across it.
Care Quality Commission enforcement policy 28
Enforcement powers we will use to hold a provider to account
(criminal powers)
Simple cautions A simple caution ensures that there is a formal
record of an offence when a person has admitted to it, but is not
prosecuted. There is no obligation on a provider to accept a
caution and, where the offer of a caution is refused, we will
consider prosecution. We will consider using a simple caution when:
• We have evidence of an offence and that evidence is sufficient
that we would be able to
bring a criminal prosecution.
• Although we could prosecute, we consider that achieving
improvements without initiating lengthy and costly proceedings is a
realistic alternative and is more proportionate than proceeding
with prosecution.
• The provider has demonstrated to us that they will be able to put
these improvements in place within a reasonable timescale.
• The Code for Crown Prosecutors indicates that this option would
be appropriate.
• The offence has an insubstantial impact on people using the
service.
Penalty notices Paying a fixed penalty enables a registered person
to avoid a potential prosecution for an offence. It is only
appropriate to issue a penalty notice where CQC would have been
entitled to prosecute. CQC has discretion over whether to serve a
fixed penalty notice as an alternative to a prosecution. There is
no obligation on a registered person to pay the sum under a penalty
notice and, if a registered person decides not to pay the penalty,
we will consider using other enforcement powers. Failure to pay
sums under a penalty notice will normally lead to a prosecution.
The power to issue a penalty notice enables proportionality in
specific circumstances. It also enables CQC to ‘send a message’
where there are recurrent beaches across a sector. Use of fixed
penalties to multiple providers within a sector can make it clear
that the issue of concern will not be tolerated, but also avoids
the need to prosecute every person in breach. It can also signal
the importance of the regulatory requirement and that we may
proceed to prosecution if there is no improvement. Any fixed
penalty paid to CQC is not retained but must be passed on by CQC to
the Secretary of State. The relevant legal requirements and current
levels of penalties are set out in appendix A. We will consider
using the power to issue penalty notices when:
Care Quality Commission enforcement policy 29
• We have evidence of an offence and that evidence is sufficient to
bring a criminal prosecution.
• Although we could prosecute, we consider that achieving
improvements without initiating lengthy and costly proceedings is a
realistic alternative and is more proportionate than proceeding
with prosecution.
• The offence has an insubstantial impact on people using the
service.
Prosecution Prosecution can be used to: • Hold a registered person
to account for breaches of prosecutable fundamental standards,
or
for failing to comply with conditions of registration.
• Enforce the offence of carrying on a service without
registration, in which case we may prosecute the person who appears
to be carrying it on.
• Ensure accountability for any person who obstructs us in the
course of an inspection or any person who makes a false or
misleading statement in an application to be registered with
us.
Where appropriate, we may prosecute at the same time as taking
other enforcement action, for example alongside urgent procedures.
We may also prosecute more than one offence at the same time. There
may be occasions where, even if the above criteria are satisfied,
we will decide to serve a Warning Notice as an alternative to
immediate prosecution. However, CQC will generally prosecute
providers where there are serious, multiple or persistent breaches
of the fundamental standards (those regulations with prosecutable
clauses that specifically relate to harm or the risk of harm)
without issuing a Warning Notice first. Failure to make the
improvements set out in a Warning Notice is likely to lead to a
prosecution. Although we are not required by law to publish details
of all criminal law procedures that we undertake, we have a general
power to publish this type of information and will normally do so.
We must publish information about any offence for which a
registered person has been convicted. All investigations of
criminal offences will be carried out with regard to the Police and
Criminal Evidence Act 1984 (PACE) principles and Codes of Practice.
Where another regulator has the power to prosecute, we will
coordinate our activity with them at an early stage to ensure the
right action is taken, to avoid inconsistency, and to ensure that
any proceedings taken are for the most appropriate offence. Where
we successfully prosecute, the court will decide on the penalty to
be imposed. Where someone is charged with more than one offence,
the court may order separate penalties in relation to each
conviction. The court may impose a prison sentence as well as, or
instead of, a fine following conviction for carrying on a regulated
activity without being registered. The offences and current maximum
court fines are set out in appendix A.
Care Quality Commission enforcement policy 30
We will consider using our powers to prosecute where: • The breach
of legislation is assessed by us to be serious and there are
multiple or persistent
breaches.
or
• We have sufficient evidence so there is a realistic prospect of
conviction.
• We assess that it is in the public interest for us to use our
powers of prosecution. In making decisions about whether to
prosecute, we will be guided by the Code for Crown
Prosecutors.
Holding individuals to account through criminal prosecutions or
using other powers CQC’s enforcement activity mostly concerns
providers and their liability as the body carrying on regulated
activities. However, CQC can use its enforcement powers to hold
certain individuals who work for providers to account. Those
individuals can be directors, managers or the secretary of a
corporate body (or a person purporting to act in that capacity), or
an officer of an unincorporated association or member of its
governing body. We will consider holding individuals to account by
prosecuting them where: • An offence has been committed with their
consent or connivance, or is attributable to
neglect on their part.
• There is clarity about the individual’s accountability as opposed
to the service provider.
• There is a realistic prospect of conviction and we assess that it
is in the public interest for us to use our powers of
prosecution.
We may also hold individuals to account by ensuring they are not
employed in a role they are not fit for. We can do this by
cancelling the registration of a registered manager, or by refusing
a new registration where we consider an individual is not a fit and
proper person. For an existing provider, we can request that they
provide assurance that directors are fit for their role. The
regulations also establish a fit and proper person requirement for
directors or individuals working in an equivalent role. We may
request the chair or equivalent of an organisation to carry out
that test and confirm the fitness of the individual director in
writing.
Unregistered providers It is an offence to provide regulated
activities in England without registering with CQC. It is a
provider’s responsibility to register. Unless people are at
immediate risk of harm, we will usually advise an unregistered
provider of the need to register in the first instance. However, in
the following instances we will rapidly take enforcement action
against all appropriate persons.
Care Quality Commission enforcement policy 31
• If a provider continues to provide regulated activities without
registration.
• If we have grounds to believe that a provider is knowingly
choosing not to register.
• If an unregistered provider places people at risk of harm. This
enforcement can include prosecution (which can lead to a fine or
imprisonment) and/or other actions such as obtaining an
injunction.
Care Quality Commission enforcement policy 32
6. Representations and appeals
Representations Registered persons have the right to make
representations to us about certain types of enforcement action. We
have produced separate detailed guidance about representations on
the following, available on our website: • Warning Notices.
• A Notice of Proposal to impose, vary or remove conditions of
registration.
• A Notice of Proposal to suspend a registration, or to extend the
period of a suspension of registration.
• A Notice of Proposal to cancel a registration.
Appeals Registered persons have the right to appeal to the
First-tier Tribunal (Care Standards) against enforcement action
using the civil enforcement procedures. This includes action under
urgent procedures but, in those cases, the Tribunal will ensure any
appeal is fast tracked. We have produced separate detailed guidance
about this on our website. Appeals must be lodged within 28 days of
the service of: • A Notice of Decision.
• A notice of imposed, varied or removed conditions using the
urgent procedures.
• A court order to cancel a registration using urgent procedures.
There is no right of appeal to the Tribunal in relation to Warning
Notices, penalty notices or conviction for offences. CQC offers
providers that are rated, the opportunity to request a review of
their ratings. That review is not a statutory right of appeal, but
a matter of CQC’s policy. It is separate to the procedures for
representations and appeals on enforcement and registration
decisions.
7. Publication and notification of enforcement action
The regulations require and authorise us to publish certain
information relating to enforcement action. We are required by law
to publish certain details of civil and criminal enforcement. We
are also required by law to publish details of any action taken
under CQC’s urgent powers. Information about the enforcement action
that we take will be included in our inspection reports. We will
also publish on our website, a summary of information about the
enforcement action taken against each provider and information
about our enforcement activity overall. We send copies of notices
relating to enforcement action to a number of third parties, such
as commissioners and other regulators. Generally, these
notifications are required in the Care Quality Commission
(Registration) Regulations 2009, but we will also inform any other
persons that we consider appropriate. We will notify commissioners
whenever our activity has an impact on the capacity or
configuration of a health and social care economy. Where changes to
capacity or configuration are made as a result of our findings but
without formal enforcement – for example, if a provider makes rapid
changes and we decide that enforcement would no longer be
proportionate – we will still endeavour to always notify
commissioners.
Care Quality Commission enforcement policy 34
Appendix: Offences and fines
Fixed penalties
Offence Penalty
Failure to comply with regulations about quality and safety (see
Regulation 22 of the Health and Social Care Act 2008 (Regulated
Activities) Regulations 2014 )
Provider Manager
£4,000 £2,000
£4,000 £2,000
Carrying on a regulated activity while registration is suspended
£4,000
Managing a regulated activity while registration is cancelled or
suspended £2,000
Failure to provide an updated statement of purpose (see Regulation
12 of the Care Quality Commission (Registration) Regulations
2009)
Provider Manager
£1,250 £625
Failure to make required notifications (see Regulations 14-18 of
the Care Quality Commission (Registration) Regulations 2009)
Provider Manager
£1,250 £625
Failure to provide a statement about fees chargeable (see
Regulation 19 of the Care Quality Commission (Registration)
Regulations 2009)
Provider Manager
£1,250 £625
Failure to observe certain requirements relating to termination of
pregnancy (see Regulation 20 of the Care Quality Commission
(Registration) Regulations 2009)
Provider Manager
£1,250 £625
Failure to provide documents or information £300
Failure to provide an explanation of any relevant matter £300
Care Quality Commission enforcement policy 35
Prosecution The Legal Aid, Sentencing and Punishment of Offenders
Act 2012 and regulations made under that Act have made changes to
the maximum penalties outlined in the table below. The maximum
limit on fines previously imposed on summary conviction for amounts
of £5,000 or more has been removed.
Offence Maximum fine
Failure to comply with regulations about quality and safety (see
Regulation 22 of the Health and Social Care Act 2008 (Regulated
Activities) Regulations 2014)
Unlimited
or 12 months
Offences relating to suspension or cancellation Unlimited
False descriptions of concerns Unlimited
False statements in applications £2,500
Obstructing entry and inspection £2,500
Failure to provide documents or information £2,500
Failure to provide an explanation of any related matter
£2,500
Failure to display performance assessment (see Regulation 20A of
the Health and Social Care Act 2008 (Regulated Activities)
Regulations 2014) £100
Note: some lesser requirements have a maximum court fine of
£2,500.
Contents
Introduction
2. Our approach to using our enforcement powers
3. Requiring improvement to protect people from harm or the risk of
harm
4. Using civil powers to protect people from harm or the risk of
harm and to improve care standards
5. Holding providers and individuals to account
6. Representations and appeals
Appendix: Offences and fines